Ozempic is facing increased competition from compounded versions and rival drugmakers, while potential side effects, including suicidal thoughts and hair loss, have spurred investigations into it and similar drugs.
Four recent updates on the Type 2 diabetes drug:
1. Compounded solutions
As the FDA investigates compounded versions of Ozempic, its maker Novo Nordisk filed more lawsuits against spas, clinics and compounding pharmacies for allegedly selling unapproved copycats. The FDA warned clinicians Dec. 21 about possible infection risks tied with these solutions, reasoning the agency can't confirm the drugs' sterility.
The FDA said it has received five reports of adverse events from the counterfeit products, which were not severe and similar to Ozempic's side effects.
Between 2021 and 2023, calls to U.S. poison control centers about overdoses on Ozempic and Wegovy, Novo Nordisk's drug for chronic weight management, nearly quadrupled. Fifty-five poison centers saw about 3,000 calls for Ozempic and Wegovy in 2023; two years prior, that number was 607.
Compounded versions might be behind the surge in calls, national officials said, because these solutions require patients to draw their own doses instead of receiving name-brand pre-filled pens.
2. Side effects
The FDA launched an inquiry into whether hair loss, aspiration and suicidal thoughts may be side effects of glucagon-like peptide-1 receptor agonists. Popular GLP-1s include Ozempic, Mounjaro, Saxenda, Trulicity and Wegovy.
The FDA said Jan. 2 it is "evaluating the need for regulatory action" after receiving reports of alopecia, aspiration and suicidal thoughts in people using these drugs for diabetes and weight loss. The agency said the news "means that the FDA has identified a potential safety issue, but it does not mean that the FDA has identified a causal relationship between the drug and the listed risk."
Other potential side effects, which have gained international attention, are suicidal thoughts and self-harm. In July, the European Medicines Agency began reviewing GLP-1s after Icelandic patients reported thoughts of suicide and self-harm. Recently, a National Institutes of Health study did not find a link between the drugs and suicidal thoughts.
3. Potential indications
In a recent study of about a dozen GLP-1s, researchers found the medications suppressed heart inflammation in mice. The results hint at possible treatment avenues for the popular drug class, including heart disease, kidney disease, Alzheimer's disease and Parkinson's disease.
"The anti-inflammatory actions of GLP-1 are likely in part organized through a subset of brain neurons," said Daniel Drucker, MD, the study's lead author, who works at Mount Sinai Hospital-Toronto.
4. Competitors
Ozempic and Wegovy's top competitors are Eli Lilly's Mounjaro and Zepbound, and the drugmaker is nipping at Novo Nordisk's heels.
In early January, Eli Lilly launched a direct-to-consumer site to sell prescription drugs, including its weight loss medications. The service includes disease management resources and free deliveries. Other pharmaceutical companies are likely to follow Eli Lilly's lead, experts told CNBC.
Older weight loss drugs are also rising in popularity as patients seeking new GLP-1s face insurance and cost barriers. For example, prescriptions for bupropion — an antidepressant with a side effect of weight loss — increased 29% between 2017 and 2023. Also, prescriptions for phentermine — a weight loss drug the FDA approved in 1959 — rose 34% in the last six years.